Classification of Class I, II and III medical devices

The country has strict classification for medical devices: Class I, Class II, Class III!

The three types of medical devices are medical devices, which must be strictly controlled. They are medical devices implanted into the human body to support and maintain life, which are potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled. Now let's get to know!
Class I medical instruments include: basic surgical knife "Surgical knife handle and blade, skin knife, wart peeling knife, willow blade, blade, shaver, dandruff scraper, pick knife, sharp knife, pedicure knife, nail repair knife, dissecting knife, etc.".

Class II medical devices: (a) ordinary diagnostic devices (6820): thermometer and sphygmomanometer; (b) Physical therapy and rehabilitation equipment (6826): magnetic therapy apparatus; (c) Clinical laboratory analysis instruments (6840): household blood glucose analyzer and test paper; (d) Equipment and appliances in operating room, emergency room and consulting room (6854): portable oxygen generator for small medical oxygen generator; (e) Medical health materials and dressings (6864): use absorbent cotton and medical absorbent gauze; (f) Medical polymer materials and products (6866): condoms, contraceptive caps, etc.
Class III medical devices: A. disposable sterile medical devices 1. disposable sterile syringes; 2. Disposable infusion set; 3. Disposable blood transfusion apparatus; 4. Disposable anesthesia puncture kit; 5. Disposable intravenous infusion needle; 6. Disposable sterile injection needle; 7. Disposable plastic blood bag; 8. Disposable blood sampler; 9. Disposable burette infusion set. B. Orthopedic implants and medical devices 1. Surgical implants and joint prostheses; (Excluding disposable sterile medical devices, hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents, 6846 implant materials and artificial organs, 6877 interventional devices), etc.